A Proof-of-Concept Study Evaluating EOM613 in COVID-19 Infected Patients With Severe Symptoms

Summary

The purpose of this study is to evaluate the safety, tolerability and preliminary efficacy of EOM613, a peptide nucleic acid with novel immune-modulating properties, in treating patients with severe COVID-19 infections. This proof-of-concept study is the first clinical trial of EOM613 in this patient population.

Timeline

Start

2021-08-09

Primary completion

2022-02-28

Completion

2022-03-30

Publications

• Background Advanced Viral Research Corp. (ADVR). ADVR reports AVR118 inhibits inflammatory arthritis in animal model and in rheumatoid arthritis patients in human clinical trial. ADVR press release, PR Newswire, December 3, 2003.
• Background Chasen M, Bhargava R, Hirschman SZ, Taraporewala I. Phase II study of OHR/AVR118 in anorexia- cachexia. Abstract of poster presentation at the 7th Cachexia conference, Kobe/Osaka, Japan, December 9-11, 2013. J Cachexia Sarcopenia Muscle 2013;4(4):335-6.
• Background Chasen M, Hirschman SZ, Bhargava R. Phase II study of the novel peptide-nucleic acid OHR118 in the management of cancer-related anorexia/cachexia. J Am Med Dir Assoc. 2011 Jan;12(1):62-7. doi: 10.1016/j.jamda.2010.02.012. Epub 2010 May 15.
• Background COVID-19 Treatment Guidelines, Interleukin-6 Inhibitors. National Institutes of Health. https://www.covid19treatmentguidelines.nih.gov/therapies/immunomodulators/interleukin-6-inhibitors/. Updated April 21, 2021. Accessed August 24, 2021.
• Background Diao L, Meibohm B. Pharmacokinetics and pharmacokinetic-pharmacodynamic correlations of therapeutic peptides. Clin Pharmacokinet. 2013 Oct;52(10):855-68. doi: 10.1007/s40262-013-0079-0.
• Background D'Olimpio JT, Chasen MR, Sharma R, Diego M, Gullo V, MacDonald N. Phase II study of AVR118 in the management of cancer-related anorexia/cachexia. Doi: 10.1200/jco.2009.27.15_suppl.e20631 (abstract presentation). Journal of Clinical Oncology 2009; 27, No. 15_suppl., e20631-e20631.
• Background D'Olimpio JT, Hirschman SZ, Shtemer Z, Didiego M. Anti-cachectic effects of a novel peptide nucleic acid: Preliminary results of a phase I/II clinical trial. Doi: 10.1200/jco.2004.22.90140.8087 (abstract presentation). Journal of Clinical Oncology. July 15, 2004; 22, no. 14_suppl 8087-8087.
• Background Friedland B. In vitro antiviral activity of a peptide-nucleic acid solution against the human immunodeficiency virus and influenza A virus. J R Soc Health. 1991 Oct;111(5):170-1. doi: 10.1177/146642409111100505.
• Background Hirschman SZ, Chen CW. Peptide nucleic acids stimulate gamma interferon and inhibit the replication of the human immunodeficiency virus. J Investig Med. 1996 Aug;44(6):347-51.
• Background Hirschman SZ. Activation of human monocytes/macrophages by OHR/AVR118 promotes both pro-and anti-inflammatory phenotypes. Available: https://www.scirp.org/journal/PaperInformation.aspx?paperID=42617. Accessed August 24, 2021. Adv Bioscience Biotechnology. 2014, 5:161-168.
• Background Hojyo S, Uchida M, Tanaka K, Hasebe R, Tanaka Y, Murakami M, Hirano T. How COVID-19 induces cytokine storm with high mortality. Inflamm Regen. 2020 Oct 1;40:37. doi: 10.1186/s41232-020-00146-3. eCollection 2020.
• Background Lazzarino DA, Diego M, Musi E, Hirschman SZ, Alexander RJ. CXCR4 and CCR5 expression by H9 T-cells is downregulated by a peptide-nucleic acid immunomodulator. Immunol Lett. 2000 Nov 1;74(3):189-95. doi: 10.1016/s0165-2478(00)00258-3.
• Background Lazzarino DA, de Diego M, Hirschman SZ, Zhang KY, Shaikh S, Musi E, Liaw L, Alexander RJ. IL-8 and MCP-1 secretion is enhanced by the peptide-nucleic acid immunomodulator, Product R, in U937 cells and primary human monocytes. Cytokine. 2001 May 21;14(4):234-9. doi: 10.1006/cyto.2001.0867.
• Background Levett PN, Hirschman SZ, Roach TC, Broome H, Alexander RJ, Fraser HS. Randomized, placebo-controlled trial of product R, a peptide-nucleic acid immunomodulator, in the treatment of adults infected with HIV. HIV Clin Trials. 2002 Jul-Aug;3(4):272-8. doi: 10.1310/N34A-653T-ABF5-8Q1R.
• Background Scherger S, Henao-Martinez A, Franco-Paredes C, Shapiro L. Rethinking interleukin-6 blockade for treatment of COVID-19. Med Hypotheses. 2020 Nov;144:110053. doi: 10.1016/j.mehy.2020.110053. Epub 2020 Jun 27.
• Background Alexander R.J., Meyer K.A., Camposano E., Lazzarino D.A., De Diego M. Product R induces differentiation of the human myelocytic leukemia cell line HL-60. American Association for Cancer Research Special Conference (Proteases, Extracellular Matrix and Cancer). Hilton Head Island, SC, USA, 2002.

Drugs

Indications